Mass Torts - Xarelto

Mass Torts - Xarelto

Introduction

It appears that there are more drugs that cause pain than relieve it. Case in point: Xarelto. Generally known as Rivaroxaban, this drug is as an anticoagulant, a blood thinner that is used to reduce the risk of blood clots and strokes. Lately, however, this "new generation" blood thinner has been linked to an increased risk of hemorrhages, strokes, epidural hematoma, pulmonary embolism, and deep vein thrombosis. The drug does not have an antidote, and in lawsuits filed by people who say they were injured by the drug, former Xarelto users say they were not warned sufficiently about its risks.

Lawsuits have been filed against Johnson & Johnson's subsidiary Janssen Pharmaceuticals, Inc., which allege that the drug's use leads to uncontrollable bleeding as a patient's blood doesn't properly clot, even from minor cuts. Pending lawsuits claim that defendants did not adequately warn patients of Xarelto's side effect. In 2012, the FDA reported that three times more people died from adverse events while on Xarelto compared to other blood thinners such as Warfarin.

One of the lawsuits alleges that Xarelto's once-a-day dosing leaves patients vulnerable to blood clots and strokes for a portion of the day. Other anticoagulants are taken twice daily to improve the balance of the amount of the drug in the body throughout the day. Furthermore, a 2014 study found the amount of Xarelto in a patient's body fluctuated more than three times as much as other comparable anticoagulants taken twice daily.

How to use Xarelto?

If you are taking this medicine to prevent blood clots after knee or hip surgery or during hospital stay and after discharge, the dose is usually taken once a day. If you are taking this medication to prevent strokes and blood clots that can form due to abnormal heartbeat, the dose is usually taken once a day for dinner. If you are taking Rivaroxaban powder to treat blood clots, a person usually takes a double dose daily for the first three weeks, and then once a day. To reduce the risk of her blood clots again, the drug is usually taken once a day. Carefully follow your doctor's instructions. Do not increase your dose, take it more often, or stop taking it unless your doctor tells you to.

A 10 milligram tablet can be taken with or without food. 15 milligrams and 20 milligrams tablets should be taken with food. If you have any questions about how to take Rivaroxaban powder, ask your doctor or pharmacist.

If you can't swallow the whole tablet, you can crush it and mix it with appleauce. Eat all the mixture immediately. Do not prepare a feed for future use.

If you are giving this medicine through a stomach tube (nasogastric or gastric tube), ask your healthcare professional for detailed instructions on how to combine it and give it properly.

News

October 16, 2019: The FDA Approves J&J, Bayer's Xarelto

On Monday, Oct.14, Johnson & Johnson's (J&J) subsidiary Janssen Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) approved Xarelto (rivaroxaban) for the prevention of blood clots in acutely ill patients without a high risk of bleeding during and after hospitalization.

Xarelto is an anticoagulant manufactured by Bayer and jointly marketed by Janssen Pharmaceuticals. Including the latest approval, Xarelto now has eight indications, six of which are specifically for the treatment, prevention, and reduction in the risk of recurrence of blood clotting.

Xarelto has been allegedly linked to causing uncontrollable bleeding, which leads to unexpected serious injuries and even death. Xarelto lawsuits are consolidated under the federal multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) in the Eastern District of Louisiana.

Mar 26, 2019: Xarelto Defendants Announce A Whopping $775M Settlement

A favorable settlement amounting to a total of $775 million was announced on Monday by Bayer AG and Johnson & Johnson’s subsidiary Janssen Pharmaceuticals to resolve over 25,000 lawsuits pending in the U.S. courts over Xarelto, their blockbuster blood thinner.

The drug is prescribed mainly to prevent and treat blood clots and lower the risk of deep-vein thrombosis (DVT), pulmonary embolism, and stroke; it was jointly developed by the two defendants who have agreed to settle the lawsuits without admitting liability under the agreement. Allegations hurled by the plaintiffs included uncontrollable and irreversible bleeding leading to severe injuries and even death. Claims also included failure to warn doctors and patients about the bleeding risks, claiming the injuries could have been prevented had adequate warnings been provided.

The settlement will resolve both state and federal cases. As per  the court papers, the cost will be split equally between the two defendants. A statement was released by Bayer stating, ‘’the settlement allows the company to avoid the distraction and significant cost of continued litigation.” Also, some of Bayer’s settlement costs will be offset by liability insurances. J&J announced through a statement, it continued to believe in the safety of Xarelto. A detailed settlement document had not been filed as of Monday midday.

Other than the state filed cases, federal cases belong to multidistrict litigation, MDL No. 2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation, presided by Judge Fallon in the Eastern District of Louisiana.

Aug 31, 2018: Defendants Win Another Xarelto Injury Lawsuit

The manufacturers of the blood thinner drug Xarelto won another case filed against them over the drug's alleged excessive bleeding effect. Philadelphia Court of Common Pleas announced the verdict after a four-week trial against Bayer and Johnson & Johnson.  

The case involves the allegations by a 63-year-old New Jersey resident that he suffered “gastrointestinal bleeding" under Xarelto treatment for his pulmonary embolism. The plaintiff had been prescribed the drug, which he continued to consume from November 2014 to December 2015. In his 2016 complaint, he alleges inadequate warnings regarding the health risks of the drug required him to be hospitalized for four days due to excessive bleeding. The jury ruled in favor of Bayer and J&J over claims that they failed to provide sufficient health risk warning, awarding them another victory in the massive Xarelto litigation.

Xarelto multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) has more than 22,250 lawsuits claiming uncontrolled internal bleeding as a serious side-effect. The MDL is overlooked by Judge Fallon in the Eastern District of Louisiana.

June 28, 2018: Federal Preemption Talks In Process Over Xarelto Lawsuits

Bayer and Johnson & Johnson are seeking interlocutory appeal over Xarelto lawsuits filed against them, asking the U.S. Court of Appeals for the Fifth Circuit to dispose of claims in the litigation, avoiding the need for further trials. An earlier motion filed by the defendants for federal preemption was rejected by Judge Fallon. A status conference to hear oral arguments regarding certifying the appeal was held on June 27.

As per the motion filed by Bayer and J&J on June 4, the enormous time required to resolve almost 1,200 Xarelto claims could be reduced by passing a pre-emption law in their favor. The defendants asserted that this would save the effort of the judicial system as well as the parties involved in the litigation. In the response filed on June 14, the plaintiffs debated that the federal preemption issue had already been concluded by the court using well-defined existing law and that granting the interlocutory appeal would unnecessarily delay the litigation.

Xarelto bellwether trials conducted in 2017, concluded with jury favoring the defendants in all three trials. Lawsuits claiming uncontrolled bleeding due to the blood thinner drug are consolidated as part of multidistrict litigation (MDL No.2592; In Re: Xarelto (Rivaroxaban) Products Liability Litigation) presided over by Judge Fallon in the Eastern District of Louisiana.

Side effects

Mild injuries or minor bleeding (such as runny nose, bleeding from the cut) are possible. 

These drugs can cause severe bleeding if they severely affect your blood-clotting proteins. Tell your doctor immediately if you have any signs of severe bleeding, including: unusual pain / swelling / discomfort, unusual injuries, prolonged bleeding from cuts or gums, continuous / normal oral discharge, severe / long menstrual flow, pink urine / black, coughing up blood, bloody vomiting or looking like coffee grounds, headache, dizziness / fainting, unusual or persistent fatigue, bloody stools / dark / waiting, difficulty swallowing.

Get medical help right away if you have symptoms of severe bleeding, including: hallucinations, confusion, slurred speech, weakness in one side of the body.

Excessive allergic reactions to this drug are rare. However, get medical help immediately if you notice any signs of severe allergies, including: rash, itching / swelling (especially of the face / tongue / throat), severe dizziness, difficulty breathing.

Precautionary measures

Before taking Rivaroxaban powder, tell your doctor or pharmacist if you have a virus in it; or if you have other physical ailments. This product may contain inactive ingredients, which may cause allergic reactions or other problems. Talk to your pharmacist for more information.

Before using this medication, tell your doctor or pharmacist your medical history, in particular: liver disease, kidney disease, bleeding problems (such as diarrhea / bleeding, cerebral hemorrhage), stroke, artificial heart valves, recent trauma / major surgery, trauma blood clots (such as anemia, hemophilia, thrombocytopenia), frequent falls / injuries, relapses, clotting disorders (antiphospholipid syndrome), certain enzyme problems (such as galactose intolerance,) deficiency of Lapp lactase, glucose-galactose malabsorption).

It is important that all your doctors and dentists know that you are taking Rivaroxaban powder. Before surgery or other dental / dental procedures, tell your doctor or dentist that you are using this medication.

These drugs can cause bleeding in the stomach. Daily use of alcohol while taking this medication will increase the risk of miscarriage. Reduce alcohol consumption. Ask your doctor or pharmacist how safe you can drink alcohol.

This drug can cause bleeding. To reduce the risk of cuts, bruises, or damage, use extreme caution with sharp objects such as safety tools and nail scissors. Avoid activities such as social media. If you fall or injure yourself, especially if you have a headache, contact your doctor immediately. Your doctor may need to check for hidden bleeding that could be worse.

Older adults can be very sensitive to the side effects of this drug, especially bleeding.

During pregnancy, the drug should be used only when it is clearly needed. 

This drug can pass into breast milk. Consult your doctor before breastfeeding.